Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST Against COVID-19 (MVA-SARS2-ST)

A Multi-center Phase Ib Trial to Assess the Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST in Adults

Multi-center phase Ib study to evaluate the Modified Vaccinia Virus Ankara (MVA) vaccine against SARS-CoV-2 in seronegative (Part A) and previously SARS-CoV-2-vaccinated individuals (Part B).

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Biological: MVA-SARS-2-ST

Detailed Description

The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing a stabilized SARS-CoV-2 spike protein (S).

This will be a phase Ib multi-center study in approximately 60 adults aged 18-64 years.

Part A (N=24 seronegative subjects). Each participant will receive two single injections, 28 days apart.

• low dose ≥ 1 x 10e7 IU (N=8)
• middle dose ≥ 5 x 10e7 IU (N=8)
• high dose ≥ 1 x 10e8 IU (N=8)

Part B (N=36 previously mRNA vaccinated subjects). Each participant will receive a single injection.

• low dose ≥ 1 x 10e7 IU (N=12)
• middle dose ≥ 5 x 10e7 IU (N=12)
• high dose ≥ 1 x 10e8 IU (N=12)

All participants will be followed up for safety until D168.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20251
    • CTC North
  • NRW
    • Cologne, NRW, Germany, 50937
      • Uniklinik Koln

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written informed consent.
2. Healthy male and female adults aged 18 - 64 at time of informed consent.
3. Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening.
4. Female participants: non-pregnant, non-lactating with negative pregnancy test.
5. Females who agree to comply with the applicable contraceptive requirements of the protocol.
6. ≥ 6 months fully vaccinated with a (conditionally)licensed mRNA vaccine against COVID-19 (Part B only)

Exclusion Criteria:

1. Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
2. Previous rMVA immunization.
3. Previous immunization with investigational vaccine against COVID-19.
4. Previous immunization with EUA/conditionally licensed vaccine against COVID-19 (not applicable to Part B).
5. Evidence of active SARS-CoV-2 infection
6. Known allergy to the components of the MVA-SARS-2-ST vaccine product or history of life-threatening reactions to vaccine containing the same substances.
7. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
8. Evidence in the participant's medical history or in the medical examination that might influence either the safety of the participant or the absorption, distribution, metabolism or excretion of the investigational product.
9. Clinically relevant findings in ECG or significant thromboembolic events in medical history.
10. Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c ≥ 7.0).
11. Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ≥ 1 x 10E7 IU (low dose) in seronegative subjects; ≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 & 28) in seronegative subjects	Biological: MVA-SARS-2-ST; i.m. vaccine administration
Experimental: ≥ 5 x 10E7 IU (middle dose) in seronegative subjects; ≥ 5 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 & 28) in seronegative subjects	Biological: MVA-SARS-2-ST; i.m. vaccine administration
Experimental: ≥ 1 x 10E8 IU (high dose)in seronegative subjects; ≥ 1 x 10E8 IU MVA-SARS-2-ST Intervention: Biological: MVA-SARS-2-ST vaccinations (days 0 & 28) in seronegative subjects	Biological: MVA-SARS-2-ST; i.m. vaccine administration
Experimental: ≥ 1 x 10E7 IU (low dose); ≥ 1 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects	Biological: MVA-SARS-2-ST; i.m. vaccine administration
Experimental: ≥ 5 x 10E7 IU (middle dose); ≥ 5 x 10E7 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects	Biological: MVA-SARS-2-ST; i.m. vaccine administration
Experimental: ≥ 1 x 10E8 IU (high dose); ≥ 1 x 10E8 IU MVA-SARS-2-ST Intervention: Biological: Single MVA-SARS-2-ST vaccination in mRNA vaccinated subjects	Biological: MVA-SARS-2-ST; i.m. vaccine administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol	Safety and reactogenicity will be assessed by observation, questionaire and diary. Occurence of Serious Adverse Events (SAE) will be collected throughout the entire study duration.	during the entire study (up to 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who seroconverted	Magnitude of SARS-CoV-2-S specific antibody responses will be measured by ELISA and neutralization assays	during the entire study (up to 6 months)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Ludwig-Maximilians - University of Munich; Philipps University Marburg Medical Center; German Center for Infection Research; Clinical Trial Center North (CTC North GmbH & Co. KG); IDT Biologika

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: April 24, 2021
• First Submitted That Met QC Criteria: May 15, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; vaccine; MVA; booster vaccination
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: UKE-SARS-CoV-2-ST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No